Doctors Rethink Use of Custom Pharmacies

Death Toll Rises to 12 From Meningitis Tied to Injected Drug

George Cary and daughters at a memorial service in Howell, Mich., Tuesday for his wife, Lilian Cary, 67 years old, whose death was linked to fungal meningitis from steroid injections.
Associated Press

By

Jennifer Corbett Dooren and

Timothy W. Martin

Oct. 9, 2012 7:52 p.m. ET

The outbreak of a rare form of meningitis is prompting some doctors to rethink their use of a specialized type of pharmacy that created steroid injections tied to 119 illnesses and 12 deaths.

MedStar Health, a health-care provider that includes Georgetown University and Washington Hospital Center in Washington, D.C., said it is reconsidering its currently limited use of compounding pharmacies, which create alternative versions of medicines, such as liquid forms of pills. "I think the whole [health-care] industry is going to undergo some serious internal rethinking," said
Bonnie Levin,
assistant vice president for pharmacy services at MedStar.

MedStar, which owns nine hospitals in Maryland and the District of Columbia, says 99% of its medicines are made by drug manufacturers and obtained through wholesalers. It uses compounding pharmacies to make or repackage a few products, such as taking an anesthesia out of a large vial and putting it into syringes, Ms. Levin said. It also turns to compounding pharmacies when there are shortages of products like electrolytes that are used in fluids given to patients.

Western Connecticut Health Network, which includes two hospitals and three ambulatory surgical centers, last week removed all products made by New England Compounding Center, the company blamed in the contaminations, and turned to an FDA-approved manufacturer for its spinal steroid injections. WCHN is now reviewing whether it will use compounding pharmacies at all, said
Matt Miller,
the network's chief medical officer.

"What is the level of quality control at these companies?" asked Dr. Miller.

The fungal meningitis traced to injections produced by New England Compounding Center has caused illnesses and deaths in 11 states. The large compounding pharmacy in Framingham, Mass., had shipped 17,676 vials of potentially tainted methylprednisolone acetate to 75 clinics in 23 states. It surrendered its state license to operate and recalled all its products last week.

An NECC spokesman declined to comment.

New Jersey health officials said Tuesday they had identified their state's first case of fungal meningitis, in a 70-year-old man who had received a steroid injection from one of the recalled lots. The man came to an emergency room with a headache and fever; he is being treated with antifungal medication and is recovering, they said.

As many as 13,000 people were exposed to the tainted injections, and Tennessee Health Commissioner
John Dreyzehner
said Tuesday the incubation period for the disease may be longer than originally thought: between six and 42 days, rather than two and 28 days. "Some experts believe vigilance for up to three months will be necessary," he said. That means even patients who got injections in mid-July could still be at some risk.

The U.S. has about 3,000 compounding pharmacies, up from virtually none in 2000, according to the International Academy of Compounding Pharmacists. While they effectively make drugs, they are overseen by state boards of pharmacy rather than regulated like drug companies by the U.S. Food and Drug Administration.

But calls for tighter regulation are growing. Rep.
Rosa L. DeLauro
(D., Conn.) said Tuesday she plans to introduce legislation to strengthen the FDA's regulatory authority over compounding pharmacies. In a letter to Health and Human Services Secretary
Kathleen Sebelius,
Ms. DeLauro said the meningitis cases "expose dramatic gaps in our drug safety standards that create an unnecessary risk to the public health."

Compounding pharmacies are big suppliers of implanted pumps with specific dosage amounts not available from pharmaceutical companies, doctors said. They also commonly supply cardioplegic solution, which bathes the heart during open-heart surgery, and anesthesia syringes.

One reason so many clinics bought steroid injections from NECC may be a shortage of FDA-approved generic versions of the drug. Only three companies make an FDA-approved version of spinal injections containing methylprednisolone acetate.
Teva Pharmaceutical Industries
Ltd.
and Sandoz Inc. make generic versions, while
Pfizer
Inc.
produces Depo-Medrol, the branded version.

A Teva spokeswoman said the company stopped making the injection in 2010 at its Irvine, Calif., facility. The move was prompted by an FDA warning letter about manufacturing quality problems. A Sandoz spokeswoman said the company's methylprednisolone injectable product "has not been marketed in the U.S. since last year" but declined to comment further.

"The generic products are still completely unavailable for now," said Erin Fox, director of drug information at the University of Utah, which maintains a drug-shortage database on behalf of the American Society of Health-System Pharmacists.

Laxmaiah Manchikanti, a pain physician in Paducah, Ky., had bought NECC-made vials of betamethasone, an anti-inflammatory steroid, since about 2008. He chose NECC because "they can make any product you want in any size you need," he said.

The FDA-approved version, made by American Regent Inc., was available only in a larger dosage, part of which would have to be tossed away, he said. By getting 12-milligram vials from NECC, Dr. Manchikanti said he was able to cut costs per patient. Physicians aren't allowed to reuse a steroid injection vial, even if only a fraction was administered.

After the meningitis outbreak, Dr. Manchikanti stopped using compounding pharmacies. "My trust was just borderline before. But personally, I won't be using a compounding pharmacy for, I guess, 20 more years," he said.

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